While the field awaits Phase 3 data on Eisai and Biogen’s anti-amyloid antibody lecanemab, the drug’s application for accelerated approval based on Phase 2 biomarker data continues to wend its way through the regulatory system. On July 5, the U.S. Food and Drug Administration formally accepted the companies' Biologics License Application (BLA) for lecanemab, granting it priority review. This means the agency will make a final decision within six months, by January 6, 2023.
Lecanemab, aka BAN2401, follows the path established by aducanumab, which received accelerated approval last year (Jun 2021 news). On the heels of that approval, the FDA granted lecanemab breakthrough therapy status, a designation that speeds the regulatory process and allows companies to submit data as they acquire it.
Eisai/Biogen began such a rolling submission for lecanemab in September 2021, completing it this May (Oct 2021 news; May 2022 news). The submission rests on Phase 2 data showing robust plaque clearance plus a modest slowing of cognitive decline (Jul 2018 news; Nov 2018 news; Swanson et al., 2021).
Meanwhile, the Phase 3 Clarity trial of lecanemab is expected to read out this fall (Nov 2020 conference news). If the findings are positive, the companies will submit an application to the FDA for traditional approval by the end of March 2023, and will also apply for approval in Japan and Europe, according to an Eisai press release.
Lecanemab is also being evaluated in the AHEAD 3-45 secondary prevention trial, as well as the DIAN-TU Tau NexGen trial, which tests amyloid and tau therapies given together (Nov 2021 conference news).—Madolyn Bowman Rogers
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- Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RY, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. PubMed. Correction.